OrthoCor Medical
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and…
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| HI-DOW Electron Technology (Hefei) Inc., Ltd | Hefei | Anhui | Manufacturer | 5 |
Record
| Listed by | Caerus Corporation, United States |
|---|---|
| FDA product code | ILX |
| Device type | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5290 |
| 510(k) | K241395 |
| Record published | 2025-03-10 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Activ8 Knee – XL | In distribution | |
| Activ8 Wrist | In distribution | |
| Pemf NOW | In distribution | |
| Active System Back – XS | In distribution | |
| Activ8 Neck | In distribution | |
| Active System Knee – Standard | In distribution | |
| Active System Knee – XS | In distribution | |
| Activ8 Back – XL | In distribution | |
| Activ8 Ankle | In distribution | |
| Active System Ankle | In distribution | |
| Active System Elbow | In distribution | |
| Active System Shoulder | In distribution | |
| Active System Back – XL | In distribution | |
| Activ8 Universal | In distribution | |
| Active System Back – Standard | In distribution | |
| Activ8 Back – Standard | In distribution | |
| Active System Universal | In distribution | |
| Activ8 Shoulder | In distribution | |
| Active System Neck | In distribution | |
| Activ8 Back – XS | In distribution | |
| Activ8 Foot | In distribution | |
| Activ8 Elbow | In distribution | |
| Active System Foot | In distribution | |
| Active System Wrist | In distribution | |
| ONE | In distribution | |
| Activ8 Knee – XS | In distribution | |
| Activ8 Knee – Standard | In distribution | |
| Active System Knee – XL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrueStim | HI-DOW International Inc. | 5 |
| ActiPatch | Bioelectronics Corporation | 1 |
| Provant Infinity | Regenesis Biomedical, Inc. | 1 |
| Provant Therapy System | Regenesis Biomedical, Inc. | 1 |
| Disposable Applicator Cover | Regenesis Biomedical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241395 | 2024-12-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.